NCT03596827 (MIRRE) is a NA clinical trial of E. coli strain E1392-75-2A dose 1E10 CFU in Diarrhea, sponsored by NIZO Food Research.

Who is sponsoring NCT03596827?

NCT03596827 is sponsored by NIZO Food Research.

What drugs are being tested in NCT03596827?

Interventions in NCT03596827: E. coli strain E1392-75-2A dose 1E10 CFU, E. coli strain E1392-75-2A dose 1E9 CFU, E. coli strain E1392-75-2A dose 1E8 CFU, E. coli strain E1392-75-2A dose 1E7 CFU, E. coli strain E1392-75-2A dose 1E6 CFU.

Is NCT03596827 still recruiting?

NCT03596827 is currently completed. Last updated 20 March 2019.

Last reviewed 2019-03-20 · How we verify

NCT03596827: MIRRE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection

Completed NA Last updated 20 March 2019

What this trial tests

NA trial testing E. coli strain E1392-75-2A dose 1E10 CFU in Diarrhea in 30 participants. Completed in 28 February 2019.

Timeline

26 September 2018

Primary endpoint
13 November 2018

28 February 2019

Quick facts

Lead sponsor	NIZO Food Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	30
Start date	26 September 2018
Primary completion	13 November 2018
Estimated completion	28 February 2019
Sites	1 location across Netherlands

Drugs / interventions tested

E. coli strain E1392-75-2A dose 1E10 CFU — full drug profile →
E. coli strain E1392-75-2A dose 1E9 CFU — full drug profile →
E. coli strain E1392-75-2A dose 1E8 CFU — full drug profile →
E. coli strain E1392-75-2A dose 1E7 CFU — full drug profile →
E. coli strain E1392-75-2A dose 1E6 CFU — full drug profile →

Conditions studied

Diarrhea — all drugs for Diarrhea →

Sponsor

NIZO Food Research — full company profile →

Who can join

Adults 18 to 55, male only, with Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, targeted to impact on the immediate clinical symptoms upon E. coli infection. In order to make the model also suitable for dietary interventions that are aimed at support of the protective response against reinfection, the immune response triggered by the primary infection should be suboptimal. The MIRRE pilot study is set up to determine how much the primary inoculation dose of diarrheagenic E. coli should be lowered in order to result in a reduced protective response upon a secondary infection.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Low doses of diarrhoeagenic E. coli induce enhanced monocyte and mDC responses and prevent development of symptoms after homologous rechallenge.
Porbahaie M, van den Belt M, Ulfman L, Ruijschop RMAJ, et al · · 2023 · cited 2× · PMID 36607972 · DOI 10.1371/journal.pone.0279626

Verify or expand the search:

Other recruiting trials for Diarrhea

Currently open trials in the same condition.

NCT07285785 — Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea · Phase 4 · recruiting
NCT07385196 — Defining Ileorectal Syndrome: a Prospective Observational Study · recruiting
NCT07205926 — First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Yo · Phase 1 · recruiting
NCT07484412 — Efficacy and Safety of Encapsulated Bifidobacterium Longum BBH016 in Subjects With Lower Gastrointestinal Symptoms · NA · active not recruiting
NCT06801067 — A Study of SER-155 to Treat Diarrhea in People on Immunotherapy · Phase 1 · recruiting

Other NIZO Food Research trials

Trials by the same sponsor.

NCT05675163 — Antioxidant and Immune Effects of Vitamin K2 · NA · completed
NCT03547362 — Real-time Amino Acid Profiling · NA · completed
NCT03301103 — PTM202 and Modulation of Host Resistance to Diarrheagenic E. Coli · NA · completed
NCT03384030 — Exploration of the Modulation of Skin Microbiota and Odor Components by Introduction of Stress in Healthy Male Subjects · NA · completed
NCT03313791 — Postprandial Blood Amino Acid Response · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03596827 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NIZO Food Research
Last refreshed: 20 March 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03596827.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing